Eko Health is MDSAP certified and ISO 13485:2016 certified.
The following Eko products have received FDA 510(k) clearance:
- Eko CORE: K151319 and K200776
- Eko Analysis Software (EAS): K192004
- Eko Murmur Analysis Software (EMAS): K213794
- CORE 500 Digital Stethoscope: K230111 and K233609
- Eko Low Ejection Fraction Tool (ELEFT): K233409
- Eko Foundation Analysis Software with Transformers (EFAST): K251494
- CORE 300 Digital Stethoscope: K261694
Eko CORE 500 Digital Stethoscope, CORE 300 Digital Stethoscope, Eko CORE, and Eko Analysis Software also have CE marking.
For product-specific UKCA marking information, additional regulatory information, or requests for a Declaration of Conformity, please contact Eko support.
Eko Health, Inc. is dedicated to maintaining public trust in the integrity of our research-related activities. The management of financial conflicts of interest (FCOI) is crucial for safeguarding research objectivity and for compliance with federal regulations.
Eko Health, Inc. seeks to ensure the integrity of its research and to comply with the Public Health Service (PHS) requirements for institutions that seek research funding. The PHS has implemented regulations (42 CFR 50, “FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants will be free from bias resulting from investigator FCOIs.
This policy includes any research performed at Eko that is funded from NIH monies (PHS grants).
- Eko may be the primary research institution.
- Eko may be a sub-investigating/contracted research institution.
This policy includes any investigators that are participating in NIH-funded research at Eko or any subcontracting organization. The policy provides mandatory training, policy documentation and essential details on processes that investigators must follow to comply with FOCI Regulations.